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Role: Test Manager (GAMP5 Compliant Software)
Location: Oxford-based (on-site or hybrid)
Contract Duration: 6 months (potential to extend)
Key Responsibilities
* Define and implement test strategies aligned with GAMP5 and risk-based testing
* Plan and oversee testing across all phases: unit, integration, system, UAT, performance, and security
* Ensure validation activities comply with FDA 21 CFR Part 11, EU Annex 11, and GxP standards
* Create and maintain all validation documents: test plans, protocols (IQ, OQ, PQ), traceability, reports
* Lead test execution and defect management using tools like Jira/Xray
* Produce test summaries, quality metrics, and dashboards for internal stakeholders
* Continuously improve testing processes, tools, and regulatory practices
* Support software validation audits (internal and external)
Required Skills & Experience
* Degree in Computer Science, Software Engineering, or related technical field
* 3+ years in QA/testing in regulated industries (pharma, biotech, med device)
* Strong working knowledge of GAMP5 and validation requirements
* Broad experience in manual and functional testing, regression, UAT, and non-functional testing
* Proficient in test management and documentation tools (Jira, Xray, Confluence, MS Office)
* Excellent communicator with strong problem-solving and attention to detail
* Able to work independently within agile, collaborative teams
* ISTQB or equivalent certification
* Experience with automated testing frameworks
* Knowledge of Agile/Scrum, AWS/cloud, embedded systems, and IoT devices
* Familiarity with eQMS platforms (e.g., Ketryx, Cognidox)
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Contract
Job function
* Job function
Consulting
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